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NCT02190747 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
A Phase 2 study, sponsored by Clementia Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02190747 is a Phase 2 study that has completed, run by Clementia Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT02190747, a Phase 2 study, has completed, sponsored by Clementia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma agonist, will prevent HO during and following a flare-up in subjects with FOP.
Interventions
- DRUG Placebo
- DRUG Palovarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-07-14 |
| Est. Completion | 2016-05-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02190747
The ClinicalTrials.gov registry entry for NCT02190747 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clementia Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02190747 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02190747 about?
NCT02190747 is a clinical study titled "An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects". Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or a...
What is the current status of trial NCT02190747?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2014-07-14. Estimated completion is 2016-05-23.
What interventions are being tested in trial NCT02190747?
The interventions under investigation include: Placebo (DRUG), Palovarotene (DRUG).
Who is sponsoring clinical trial NCT02190747?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
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